Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K001144 |
Device Name |
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS |
Applicant |
LASERSIGHT TECHNOLOGIES, INC. |
3300 UNIVERSITY BLVD. |
SUITE 140 |
WINTER PARK,
FL
32792
|
|
Applicant Contact |
SAM MIRZA |
Correspondent |
LASERSIGHT TECHNOLOGIES, INC. |
3300 UNIVERSITY BLVD. |
SUITE 140 |
WINTER PARK,
FL
32792
|
|
Correspondent Contact |
SAM MIRZA |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 05/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|